Industries
Life Sciences
21 CFR Part 11, GxP, and validated systems, with your people moving faster instead of drowning in paper.
21 CFR Part 11 GxP ISO/IEC 42001 EU AI Act
Where every decision meets an auditor
In life sciences, the work is validated, traceable, and inspected. 21 CFR Part 11 governs electronic records and signatures, GxP governs how the work is done, and the FDA and EMA expect you to prove both. AI and automation can make teams dramatically faster here, but only if adoption is done in a way an inspector will accept.
How we help
We help R&D, quality, and commercial teams adopt AI and automation that hold up under inspection, and that people are glad to use.
- Vet the leaders for real regulated-industry and validation experience.
- Govern the systems with admissibility controls and audit trails built for GxP and Part 11.
- Document it as an ISO/IEC 42001 management system mapped to your existing quality system, not a parallel paper stack.
- Build it as governed, validated systems your team can defend.
- Secure it and, where data cannot leave your walls, run it on sovereign compute you own.
- Enable your people so compliance feels like help, and the work actually gets faster.
Request a briefing to talk through your program.